Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-01460-1
Product Name/Description	AXIOM Luminos TF, AXIOM Iconos R100 and R200, AXIOM Luminos Agile, Luminos Agile Max, AXIOM Luminos dRF, Luminos dRF Max and LUMINOS Lotus Max systems ARTG 274540 (Siemens Healthcare Pty Ltd - X-ray system, diagnostic, fluoroscopic, general-purpose, stationary, digital) ARTG 144246 (Siemens Healthcare Pty Ltd - X-ray system, diagnostic, fluoroscopic, general-purpose, stationary, analogue)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/12/2022
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	Siemens Healthcare is informing of an update to the user manual which is being issued as a preventive measure to exclude any potential risk of patient injury caused by the foot rest detaching from the patient table during an examination. If the foot rest is not connected and locked properly to the patient table, there is a risk that it could detach and the patient could slid off the table and be injured.
Recall Action	Product Defect Correction
Recall Action Instructions	Siemens are advising customers as below: 1. The user must check that the foot rest is locked into position and attached firmly every time before allowing a patient to sit or stand on it. 2. The two green bars on each side of the foot rest must be visible. 3. The foot rest must only be attached and removed when the table is horizontal. Customers are also advised to follow the instructions in the addendum to the operator manual for attaching the foot rest (customer letter and addendum will be provided to only impacted customers by Siemens). This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	1800 310 300 - Customer care - Siemens